Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine
About this trial
With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine.
Eligibility criteria
Qualifiers
Sign the informed consent form
Age 18-85 years old
Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment
Disqualifiers
Patients with decompensated heart failure
Glomerular filtration rate (eGFR)<30mL/min/1.73m 2
Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
Symptomatic hypotension or systolic blood pressure (SBP)<100mmHg at the time of inclusion or baseline
Trial design
Treatments tested in this trial
- Qishen Granules
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov